A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: bosutinib or bosutinib + aprepitant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02058277

B1871041

Details and patient eligibility

About

This is an open label, randomized, single dose, one cohort, two sequence, two period crossover study in healthy subjects. The primary objective of the study is to evaluate the effect of a single oral dose of aprepitant on the pharmacokinetic (PK) profile of a single oral dose of bosutinib in healthy subjects.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects with an informed consent document signed and dated by the subject.

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
• Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non hormonal contraception as outlined in this protocol .
• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.

Trial design

20 participants in 1 patient group

Healthy volunteers

Other group

Description:

Healthy volunteers taking a single dose of bosutinib and a single dose of bosutinib plus aprepitant in random order

Treatment:

Drug: bosutinib or bosutinib + aprepitant